Barrier contraceptive

ABSTRACT

A barrier type contraceptive is an umbrella-like device including a flexible, barrier member with a plurality of radially disposed resilient stiffening members associated therewith. The stiffening members bias the barrier member into a generally planar configuration while allowing for the device to be folded into a generally fusiform shape for insertion.

RELATED APPLICATION

This is a continuation-in-part of U.S. Pat. application of Ser. No.037,212; filed Apr. 10, 1987.

FIELD OF THE INVENTION

This invention relates generally to contraceptive devices and inparticular to barrier contraceptive devices of the diaphragm type.

BACKGROUND OF THE INVENTION

Control of conception has been an important medical endeavor for manyyears and instructions for the manufacture of contraceptive devices andcompositions are found in some of the earliest known medicalmanuscripts. Presently, contraceptive technologies rely uponpharmaceutical and mechanical methods. Pharmaceutical methods involvethe use of medicinal compounds which prevent pregnancy by interferingwith ovulation, implantation or spermatogenesis. Mechanical methods aredirected to preventing contact of ovum and sperm and involve the use ofmechanical barriers and spermicidal compounds.

Because of the increasing concern with the side effects ofpharmaceutical compositions, mechanical methods of contraception areincreasing in popularity. Additionally, concern with sexuallytransmitted diseases has engendered a renewed interest in barrier typedevices.

The cervical cap is one of the earliest types of mechanicalcontraceptives available, having been introduced over 150 years ago. Thecervical cap is a generally rigid, relatively small device fitteddirectly onto the cervix where it forms a barrier to the passage ofspermatozoa thereinto. Although the cervical cap has been available fora relatively long period of time it is of rather limited use. In orderto obtain a good fit, it is generally required that wax or lateximpressions of the cervix be taken and these impressions utilized tofabricate a custom fitted cap. Such fitting is expensive, time consumingand requires the assistance of highly trained personnel. Insertion andremoval of the cervical cap is relatively difficult and frequently mustbe done by trained personnel. The cap is generally left in place forrelatively long periods of time and this placement can encourageundesired side effects such as the growth of anaerobic bacteria in theuterus, toxic shock syndrome and mechanical damage such as cervicalerosion. Such technology is described in U.S. Pat. Nos. 4,517,970;4,401,534 and 4,467,789.

A more commonly utilized type of barrier contraceptive is the diaphragm,which has been available since the end of the 19th Century and which hasbeen in relatively wise use in the last thirty years. The diaphragmpresently utilizes is generally similar in design to that first inventedin 1882 by Dr. C. Hasse. It is comprised of a flexible rubber barrier ofgenerally circular shape having a rigid, thickened rim reinforced with ametal spring. In use, the diaphragm is inserted in the vagina so that itforms a barrier seal protecting the opening of the cervix.

While presently utilized diaphragms are quite well accepted, use of suchdevices is not without problems. The proper fitting of diaphragms isessential if reliable contraception is to be obtained. The diaphragmmust contact the vaginal wall uniformly and tightly so as to preventspermatozoa from passing therearound. Accordingly, presently availablecontraceptive diaphragms are provided in a wide range of sizes and mustbe fitted carefully by trained medical personnel. Additionally, the usermust be trained in proper methods of insertion if the function of thediaphragm is to be reliable. An improperly fitted, or improperlyinserted diaphragm may become dislodged during sexual activity therebypermitting conception to occur.

Since proper fit is so crucial to diaphragm function, women utilizingsuch devices should be carefully monitored. If a weight gain or loss ofmore than 15 pounds occurs it is generally advised that the diaphragm berefitted. Similarly, child birth, abdominal surgery or other such eventswill necessitate refitting of a contraceptive diaphragm. The rigid rimof such diaphragms can cause problems with its use. Many women cannottolerate such a device because of the size or shape of their vaginalwalls or cervix. In addition, the rigid rim can in some instances causepressure ulceration to occur. Accordingly, it will be appreciated thatthere is a need for a device which eliminates these shortcomings of thepresently available diaphragm.

Contraceptive sponges are another class of devices enjoying increasingpopularity. The contraceptive sponge is a generally flattened,cylindrical device made of resilient polyurethane foam or similarmaterials impregnated with a spermicidal compound. Such a device is notstrictly speaking a barrier insofar as it does not impose anyimpenetrable cover over the cervix. Instead, it is believed that thecontraceptive sponge functions by spermicidal action. The contraceptivesponge need not be custom fitted for individual users and accordinglymay be purchased over the counter without prescription, and for thisreason is enjoying widespread use. The contraceptive sponge is notwithout shortcomings however. In general the contraceptive sponge has alower reliability rate than does a properly fitted diaphragm. Problemsoccur because of dislodgement of the device, bypass of the device orineffectiveness of the spermicide. Dislodgement and bypass can occurduring sexual activity when the penis moves past the sponge pushing itaway from the cervix. Ejaculation can then occur in the vicinity of thecervix and spermatozoa can pass thereinto without being exposed to thespermicidal compound in the sponge.

In addition to problems of reliability, there are also problems of amechanical nature involved in the use of contraceptive sponges. In manyinstances, users have found it difficult to remove such sponges from thevaginal cavity. In those cases, the sponge tears or breaks therebypreventing removal, and medical assistance must be resorted to removeall traces of the sponge. In other instances, the use of contraceptivesponges has been associated with toxic shock syndrome. Some women alsohave problems retaining the sponge for a sufficient length of time toinsure contraception.

Accordingly, it will be appreciated that there is a need for acontraceptive device which enjoys the reliability and general safety ofheretofore employed contraceptive diaphragms and which has theadditional advantages of presently utilized contraceptive spongesinsofar as it eliminates the need for fitting by trained personnel. Sucha contraceptive device could readily be sold over the counter in one ortwo basic sizes to accommodate most women. It may be preferable in someinstances to fabricate such devices as one time disposable items whereasin other instances a reusable contraceptive of this type will bedesired. It is further desired that such contraceptive devices berelatively easy to insert and remove and that they have sufficientflexibility so as to prevent the formation of ulcers or erosions.

The present invention provides for a barrier type contraceptivefulfilling these needs. The contraceptive of the present invention is agenerally umbrella shaped article which may be readily folded into anelongated or fusiform shape for insertion or removal. Once in place, thecontraceptive device of the present invention is adapted to expand so asto uniformly contact the vaginal walls thereby forming a tight barrierseal. The contraceptive of the present invention may be utilized inconjunction with spermicidal compounds and may further includereservoirs for such compounds as well as a handle or loop for removal.In addition to being utilized as a contraceptive device, theumbrella-like diaphragm of the present invention may be utilized as atherapeutic device adapted to release medicinal compounds into thevaginal environment. These and other advantages and features of thepresent invention will be readily apparent from the summary, drawings,detailed description and claims which follow.

BRIEF DESCRIPTION OF THE INVENTION

There is disclosed herein a barrier-type contraceptive comprised of aflexible barrier member having a plurality of radially disposedresilient stiffening members associated therewith. These stiffeningmembers are adapted to bias the barrier member into a generally planarconfiguration. Additionally, the stiffening members have sufficientflexibility to allow the device to be folded into a generally fusiformshape. In one particular embodiment, the stiffening members are joinedtogether proximate the center of the barrier so as to provide sufficientbiasing force, whereas in other instances the stiffening members arejoined together at a point eccentric with respect to the barrier member.The stiffening members may be formed from a wide variety of materials asfor example; metal, synthetic polymers, natural rubber and variouscombinations thereof. The stiffening members may be embedded in thebarrier member or laminated between two sheets of barrier membermaterial so as to be completely encapsulated thereby or they may beaffixed to at least one surface of the barrier member. In one specificembodiment, the stiffening members are made of the same material as theflexible barrier member and are provided by the thickened portionsthereof. In other instances it may be desirable to form the stiffeningmember so as to be relatively thick proximate the center of the barriermember and relatively thin proximate the perimeter thereof.

The flexible barrier member may be fabricated from a wide variety ofmaterials such as; natural rubber, synthetic rubber, silicone rubber andsynthetic polymeric materials. One material having particular utilityfor the fabrication of barrier and/or stiffening members is a copolymerof a terepthalate polyester and a polyether glycol.

In one embodiment, the barrier member is a generally conical memberhaving a circular perimeter and may for example have a diameter ofapproximately 55-95 millimeters. In other instances the barrier memberhas an oval perimeter. The conical barrier member is preferably formedfrom an elastic material and the stiffeners cooperate with the elasticmaterial so as to allow for an increase in the size of the perimeter ofthe barrier as the conical height thereof is decreased. In this manner,the device is adapted to uniformly contact its circular perimeter to thevaginal wall.

The flexible barrier member may be configured so as to include areservoir adapted to hold and selectively release a medicinal compoundtherefrom. Additionally, the device may include a handle configured soas to facilitate withdrawal thereof, as well as tactile placementindicia. The present invention also includes a generally tube-likeinserter adapted to retain the folded device therein for insertion intothe vaginal canal.

In one specific embodiment, a barrier contraceptive includes twoflexible, generally conical barrier members each having a circularperimeter and being joined at a plurality of points along those circularperimeters. At least one of the barrier members may include a pluralityof radially disposed, resilient stiffener members associated therewithand adapted to bias the barrier members into a generally planarconfiguration while allowing the device to be folded into a fusiformshape. A device of this particular configuration is particularly wellsuited for containing a medicinal compound such as a spermicidal ortherapeutic compound therein.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a particular barrier contraceptivedevice fabricated in accord with the principles of the presentinvention;

FIG. 2 is a top plan view of the device of FIG. 1;

FIG. 3 is a perspective view of the device of FIGS. 1 and 2 as foldedinto a fusiform shape;

FIG. 4 is a drawing of one particular insertion device as adapted toinsert the barrier contraceptive device of the present invention intothe vaginal cavity;

FIG. 5 is a perspective view of another barrier contraceptive devicestructured in accord with the principles of the present invention;

FIG. 6 is a perspective view of yet another barrier contraceptive deviceof the present invention;

FIG. 7 is a cut-away view of a barrier contraceptive of the presentinvention as adapted to release a medicinal compound;

FIG. 8 is a perspective view of the medicinal compound containing acapsule of the barrier contraceptive of FIG. 7;

FIG. 9A is a top plan view of still another barrier contraceptive deviceof the instant invention;

FIG. 9B is a side view, in perspective of the device of FIG. 9A; and

FIG. 10 is a top plan view of one particular design of stiffening memberadapted for use in the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to FIG. 1, there is shown a first embodiment ofbarrier-type contraceptive structured in accord with the principles ofthe instant invention. The device 10 of FIG. 1, is a generallyumbrella-like device generally comprised of a flexible barrier member12, which in this embodiment is structured as a conical member having acircular perimeter. Included in the device 10 are a plurality ofstiffening members 14 which are adapted to bias the conical barriermember into a generally planar configuration. As shown in FIG. 1, thecontraceptive device 10 is shown as biased into what is referred toherein as "a generally planar configuration," and it will be appreciatedthat said planar configuration includes the conical or openumbrella-shaped configuration illustrated with reference to FIG. 1.

In addition to biasing the barrier member 12 into a planarconfiguration, the stiffening members 14 also have sufficientflexibility so as to allow the device 10 to be folded into a generallyfusiform shape for insertion.

Referring now to FIG. 3, there is shown a folded form of thecontraceptive device 10 of the present invention. By "fusiform" is meanta generally elongated or cylindrical shape substantially as shown withreference to FIG. 3.

Referring now to FIG. 2, there is shown a top plan view of the barriercontraceptive 10 of the present invention illustrating one particularembodiment of stiffening member configuration. As it will be seen fromthe figure, stiffening members 4 are interconnected at a common locus16, proximate the center of the barrier member 12. Also, as illustrated,the barrier contraceptive 10 includes 8 stiffening members 14.

It will be appreciated that other configurations of stiffening membermay be utilized in conjunction with the present invention. For example,a larger of smaller number of stiffening members may be utilized andthose members may be joined in other manners. For example, thestiffening members 14 may fasten to a ring-like member generallyencircling the central portion of the barrier member 12. Alternatively,the stiffening members 14 may not all be joined at a central locus. Forexample, one or two pairs of the stiffening members may join at thecentral region whereas others may be unattached members. Furthermore, inaddition to being interconnected at a central portion, the stiffeningmembers 14 may be additionally interconnected at various other pointsalong the length thereof so as to form a web-like pattern. In yet otherembodiments, the stiffening members 14 may be additionally encircled bya circular stiffening member 18 (shown in phantom outline herein)adapted to aid in biasing the barrier contraceptive 10 into a deployed,substantially planar configuration. The stiffening members may bedisposed upon either surface of the barrier member 12, or they may beembedded within the barrier member 12, itself.

In use, the barrier contraceptive device 10 is folded into the generallyfusiform shape illustrated in FIG. 3 and inserted into the vagina. Thestiffening members 14 cooperate to expand the folded device 10 in amanner similar to the opening of an umbrella. Because of the flexibilityof the barrier member 12 and the biasing force of the stiffening members14 the device 10 expands until uniform contact with the vaginal walls isattained thereby forming a tight barrier. The fact that the expansionand contact is maintained by the stiffening members 14 allows for thefabrication of a device 10 having a relatively soft perimeter whichthereby avoids the danger of pressure ulceration and the like heretoforeencountered with spring rim diaphragms.

The use of such a design confers additional advantages in contraceptivereliability insofar as pressure upon the face of the barriercontraceptive device occurring during sexual intercourse will tend tofurther bias the device into a planar configuration so as to tighten theseal thereof. In this manner, the tightest seal is achieved at the timeof ejaculation, when such seal is most critical. It should be readilyappreciated that the generally umbrella-like configuration of thebarrier contraceptive disclosed herein further allows for ease ofremoval of the device insofar as it will readily fold back to the closedconfiguration when withdrawn.

The fact that the umbrella-like device disclosed herein expands toaccomodate various sizes of user is a very important feature insofar asit obviates the need to employ trained personnel for custom fitting ofdiaphragm-type devices as well as the need for dispensers to stockmultiple sizes. It is anticipated that a diameter of approximately 55-95millimeters for the expanded device, as measured across the circularperimeter thereof, should be sufficient to accomodate the majority ofwomen. Umbrella-type barrier contraceptive devices may be fabricated intwo size ranges, a first range capable of expanding to diameters of50-75 millimeters, and a second size adapted to expand from 70-95millimeters. It is further anticipated that the devices of the presentinvention may be manufactured in a single size adapted to be cut by thedispenser, or end user so as to achieve the proper size range. Forexample, the surface of the flexible barrier 12, may be marked with aline indicating where the device should be cut so as to provide a propersizing.

The fact that the umbrella type devices of the present invention neednot be custom fitted readily adapts their use for direct over thecounter sales to consumers and further suits such devices for use indeveloping countries where trained personnel are not readily available.The device of the present invention may be fabricated as a reusabledevice or may be a single service item.

The umbrella-like barrier contraceptive functions quite well to preventpregnancy, however it may utilized in combination with spermicidalcompounds to further increase the efficiency thereof in a manneranalogous to the use of spermicides with heretofore available spring rimdiaphrams. For example, spermicidal compositions may be placed withinthe conical portion of the flexible barrier 12 prior to insertion; andsimilarly, such compounds may be placed along the periphery of thedevice. When the barrier device 10 is folded into the fusiform shape,the spermicidal compound will be retained therein.

The flexibility of the present device further enhances the efficiency ofutilization of spermicidal compounds insofar as pressure upon the faceof the device, as transmitted by the stiffening members 14 will tend topush any spermicidal compound retained therein onto the subjacent cervixand along to the periphery of the device further enhancing the seal andforming a strong barrier to passage of spermatozoa. In order toaccommodate the use of such compounds, the barrier device may be furthermodified to include reservoirs and the like, and such modifications willbe described in greater detail hereinbelow.

In addition to the use of spermicidal compounds, other medications maybe employed in conjunction with a device of the present invention. Forexample, the therapeutic agent 5 Flouro-uracil is utilized as anantichondyloma compound and such an agent may be placed in a device suchas that illustrated herein, which device will then retain thechemotherapeutic agent in contact with the subjacent tissues. Similarly,agents for treating cervicitis and similar conditions may be employed.Also antiviral compounds, such as those compositions for preventingherpes or AIDs infection may be similarly utilized.

There are a wide variety of materials which may be utilized in thefabrication of the umbrella-like devices of the present invention. Thebarrier is advantageously fabricated from a flexible material havingsome degree of resiliency. Among such materials are natural rubber,silicone rubber, other synthetic rubbers, and various syntheticpolymeric materials. The stiffening members are preferably thin,flexible members and may be fabricated from a variety of materials. Thinmetal strips may be advantageously employed, as may be coiled orotherwise spring-like members. There are a wide variety of polymericmaterials having a high degree of flexibility and resiliency and suchmaterials may be advantageously employed to fabricate the stiffeners.For example fluorocarbon polymrs may be fabricated into spring-likestrips adapted to function as stiffening members as may be nylon,polyester, polystyrene, polyvinylacetate and the like.

It has been found that elastomeric materials are advantageous infabricating the devices of the present invention. Synthetic elastomers,such as polyester elastomers have been found to be of particularadvantage insofar as their physical properties (e.g.; hardness,resiliency and melting point) can be readily controlled over a widerange.

A particularly advantageous material is a block copolymer of aterepthalate polyester and a long chain polyether glycol. One suchcommercially available material is a block copolymer consisting of ahard (crystalline) segment of polybutylene terepthalate and a soft(amorphous) segment based on long chain polyether glycols. Suchmaterials are sold by the Dupont Corporation under the trade name Hytrel*. The physical properties of these polymers are determined by the ratioof hard to soft segments, as well as the makeup of the segments.Additionally, these materials are readily fabricated into finishedshapes by common techniques such as compression molding.

By control of the previously mentioned parameters these polymers can bemade relatively soft to enable their use in the fabrication of thebarrier member; or, they can be made hard and resilient so as to besuitable for use as stiffening members. Hytrel * polymers are availablein FDA approved food grades and it has been found that grade 4059FG,having a durometer hardness of 40, a flexural modulus of 55 MPa at 23°C. and a melting point of 195° C. is particularly well suited for thefabrication of barrier members; and grade 6359FG having a durometerhardness of 63, a flexural modulus of 300 MPa at 23° C. and a meltingpoint of 213° C. is particularly well suited for the fabrication ofstiffening members. It is to be understood however, that other grades ofHytrel *, as well as other polymers having similar properties maylikewise be employed.

Use of various polymeric materials or the fabrication of the barriercontraceptive of the present invention confers an advantage insofar assuch materials allow for ready cutting therethrough so as to permit theadjustment of the size of the resultant device. In some instances it maybe advantageous to utilize a combination of materials to fabricate thestiffening members. For example, the members may be fabricated as stripsof polymeric material circled by a metallic coil spring, as for example18 in FIG. 1. In yet other instances, the stiffening members may beprovided by thickened portions of the barrier member itself, as forexample by molding in a plurality of ribs. All of such variations shouldbe readily apparent to one of skill in the art.

The umbrella-like barrier contraceptive of the present invention mayfurther include an inserter adapted to facilitate the use thereof.

Referring now to FIG. 4, there is shown one configuration of insertiondevice 20 as adapted to be used in the present invention. The inserter20 is comprised of a generally tubular housing 22 adapted to retain theumbrella-like device of the present invention in its folded form. Thetubular member 22 has a plunger 24 disposed in one end thereof andadapted to eject the folded barrier device therefrom. Obviously, otherconfigurations of inserter may be similarly employed.

Referring now to FIG. 6 there is shown yet another umbrella-likecontraceptive device 30 structured in accord with the principlesdisclosed herein. The device 30 of FIG. 6 is generally similar to thatdisclosed with reference to FIG. 1 with the exception that thestiffening members 14 are not interconnected proximate the apex of thebarrier member 12, but rather are attached to a ringlike portion 32generally encircling the apex of the conical barrier member 12. Theringlike member 32 allows for the stiffening members 14 to be affixed toone another so as to allow for easy biasing of the barrier member 12,while still allowing the central portion of the barrier member 12 to beuncovered.

It will also be noted from the figure that the central portion of thebarrier member 12 is configured as a reservoir 34 adapted to hold amedicinal compound such as a spermicide or a therapeutic agent therein.While such agents may be utilized in conjunction with a device as shownin FIG. 1, the inclusion of a large reservoir 34 allows for highercapacity of such agents. It will also be noted that the device 30,includes a handle 36, formed from a loop of flexible material such as apolymeric fiber or the like, and to facilitate removal of thecontraceptive device 30 from the vagina. As depicted, the handle 36 isattached to the ring 32 and it will appreciated that by pulling upon thehandle, the device 30 is collapsed to its closed shape for withdrawal.Obviously, other such handle configurations may be similarly employed.

Referring now to FIG. 5 there is shown yet another configuration ofdevice as structued in accord with the principles disclosed herein. Thebarrier contraceptive device 40 illustrated in FIG. 5 is fabricated byaffixing two flexible, generally conical barrier members 12a, 12b alongat least a portion of the perimeters thereof. It is generally preferredthat at least one of the two barrier members 12a, 12b have stiffeningmembers associated therewith and as illustrated both barrier members12a, 12b have stiffening members 14 associated therewith.

As shown in the figure, the two barrier 12a, 12b are affixed to oneanother along a plurality of points on the perimeters thereof so as todefine a number of openings 41. A device in this configuration isreadily adapted to retain therein a relatively large amount ofspermicide or other medicinal compound and furthermore, is capable ofproviding a relatively tight seat to the vaginal walls during use. Theplurality of openings 41 allow for escape of spermicidal compoundstherefrom so as to further complete the seal. The device 40 of FIG. 5 isalso capable of folding into a fusiform shape for insertion and foldingmay be accomplished by either moving the apices of the two conicalbarrier members 12a, 12b in opposite directions from one another so asto provide a elongated, folded device or by moving the two apicestogether so as to fold one conical member inside the other.

As was mentioned previously, the device of the present invention may befurther adapted to release a medicated compound into the vagina.Referring now to FIG. 7, there is shown one such adaption. The device 50of FIG. 7 includes a flexible barrier member 12 as shown previously. Thestiffening members are not visible in this cut-away view. Also includedis a medication releasing capsule 52 adapted to retain and release amedicinal compound such as a contraceptive or therapeutic agent.

The capsule 52 which is shown in enlarged detail in FIG. 8, includes anupper 56a and lower 56b membrane adapted to release the medicinalcompound from the regions 60, 58 bounded thereby. The capsule furtherincludes an impervious barrier layer 54 extending thereacross andgenerally contiguous with the flexible barrier 12. The barrier layer 54and flexible barrier 12 cooperates to provide a contraceptive shield.

The barrier layer 54 divides the capsule 52 into two compartments 58 and60 bounded by the porous membranes 56a, 56b. Each compartment is adaptedto store and release a medicinal agent; and accordingly, the capsule canaccommodate a spermicide and a therapeutic agent. The membrane 56a, 56bcan be porous polymeric materials, perforated materials and the like.

In one embodiment, the capsule 52 can be fabricated from a foam-likematerial impregnated with a spermicide and in that sense is similar topresently utilized contraceptive sponge. Such an embodiment wouldcombine the advantages of the contraceptive sponge with those of theflexible umbrella-like device disclosed hereinabove.

Referring now to FIGS. 9A and 9B there is illustrated yet anotherbarrier contraceptive structured in accord with the principles of thepresent invention. The device 70 is generally similar to thosepreviously described insofar as it includes a flexible barrier member 72and a plurality of stiffening members 74 affixed at a common locus andadapted to maintain the barrier member 70 in a generally planarconfiguration. Where the device 70 of this embodiment differs from thosepreviously discussed is in that the barrier member 72 is of a generallyoval shape. It will be noted from the figure that the central locus ofthe stiffening member 74 is not placed in the center of the oval barriermember 72, but is placed in an eccentric location. Such placement givesan overall irregular shape to the device 70, best seen in FIG. 9B, whichis a side perspective view of the device. It will be noted that theeccentric placement of the stiffening member 74 serves to create anasymmetric profile to the device 70 such that a forward larger portionand a rearward smaller portion are defined.

In use, the contraceptive device 70 is inserted into the vaginaproximate the cervix such that the larger or forward portion is disposedtoward the ventral side of the body and the rearmost portion toward thedorsal side. It has been found that such configuration and dispositionoptimizes cervical shielding. It should be noted that while theplacement of the stiffening members 74 is depicted as being eccentric tothe barrier member 72, it may in some instances be advantageous to placethe stiffening members in a central location in conjunction with an ovalbarrier member. In other instances, an eccentrically configured set ofstiffening members can be employed in conjunction with a generallycircular barrier member to create an asymmetrically profiled device.

In general, the size of the device 70 of FIGS. 9A, 9B is similar to thatof the circular devices, i.e., a diameter of 50-95 millimeters willgenerally encompass all required sizes. In the instance of the ovaldevice both the major diameter and the minor diameter thereof, asmeasured along a central axis will each be within the stated range.

The device 70 of FIGS. 9A, 9B illustrates another feature of the presentinvention. Problemsmay occur in user verification of the location of thecontraceptive device, insofar as the barrier member 72 is relativelythin, particularly at the periphery thereof and accordingly it would bedesirable to have some means for verifying the location of thatperiphery to assure proper device placement. Toward that end, the device70 of FIG. 9A, 9B includes a plurality of molded in raised dots or bumps76 along a portion of one rim thereof. These dots 76 provide a tactilecontrast to the relatively thin barrier member 72 enabling the user toverify location of the upper rim. Obviously, other configurations suchhas a single dot, a raised bar or the like may be employed for thispurpose. In the instance of a symmetrical (i.e., circular) type ofdevice it may be desirable to place the tactile indicia along theentirety of the rim; however, in the instance of the asymmetric device70 it will generally be preferred to place such indicia along only oneend thereof so as to verify proper orientation of the device 70 as wellas proper placement thereof.

Referring now to FIG. 10 there is shown a top plan view of oneparticular configuration of stiffening member 80, structured in accordwith the principles of the instant invention. As illustrated, thisstiffening member includes individual arms 82 joined at a central locus84, each of the arms 82 terminating in a tab portion 86. It has beenfound that the tab portions 86 serve to better anchor the barrier memberand to maintain proper orientation thereof. The stiffening member 80 maybe fabricated from any of the materials previously described and it hasbeen found particularly advantageous to employ the block copolymer typematerials previously referred to. It has also been found that it isdesirable to provide a radial thickness profile to the stiffening member80 such that the central locus 84 is relatively thick whereas thetabular portions 86 and the extremities of the arms 82 proximate theretoare relatively thin. In this manner, flexibility of the rim of thecompleted device is assured and proper fit readily obtained. Typicallythe central portion 84 will be from 1-5 mm in thickness, while thetabular portions 86 will be from 0.25-3 mm thick. However, the specificthicknesses will depend upon the resiliency of the material from whichthe member 80 is fabricated.

Obviously other variations of the stiffening member 80 of FIG. 10 may beemployed. For example, and as previously discussed the central focus 84may be replaced with a ringlike open structure. Also, a larger orsmaller number of arms 82 may be included and, as illustrated withreference to the device of FIGS. 9A and 9B, the stiffening member 80 mayhave its central locus 84 disposed eccentric to the arms 82, which willthen be of differing lengths and angular relationships. In thoseinstances where the stiffening member 80 and the barrier member to whichit attaches are fabricated from the same material they may be readilyattached by a thermal lamination process. In other instances adhesivebonding may be employed.

Various other modifications of the depicted devices are possible withinthe scope of the present invention. For example, the stiffening membersmay not be separate members but may be provided by merely thickening aportion of the barrier member 12 so as to provide sufficient support andbiasing force to enable proper function of the device. In anotherembodiment, the entire carrier member 12 may be fabricated from a porousor absorbent material adapted to retain and release spermicide or othermedicinal compounds.

The umbrella-like barrier contraceptives of the present invention may bepackaged for use as a single service item in a form preloaded withspermicidal compounds. Similarly, when the device is utilized as adelivery agent for chemotherapeutic compounds it may be dispensed withthe therapeutic agent already in place. These and other modificationswill be readily apparent to one of skill in the art and accordingly theforegoing drawings, discussion and description are merely meant to beillustrative of particular embodiments of the present invention and notlimitations upon the practice thereof. It is the following claims,including all equivalents which define the scope of the instantinvention.

I claim:
 1. An intravaginal barrier type contraceptive device comprisingtwo flexible, continuous, impermeable, generally conical barrier memberseach having a circular perimeter and an apex, said members joined at aplurality of points along said circular perimeters, with the apicesoriented in opposite directions; each barrier member including aplurality of radially disposed, resilient stiffener members associatedtherewith, said stiffening members adapted to bias the barrier membersinto a generally conical configuration to uniformly contact the vaginalwall and form a tight barrier seal therewith, and having sufficientflexibility to allow said device to be folded into a generally fusiformshape for insertion and removal.